A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Part of paid clinical trials in Athens, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06283966
Phase
PHASE3
Status
Recruiting
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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BGF MDI 320/14.4/9.6 μg — DRUG
    Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
  • GFF MDI 14.4/9.6 μg — DRUG
    Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Study Details

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Key Dates

Start date
Feb 21, 2024
Status verified
May 2026
Primary completion
Dec 3, 2027
Completion
Dec 3, 2027

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BGF arm
    BGF MDI 320/14.4/9.6 μg BID
  • Experimental: GFF arm
    GFF MDI 14.4/9.6 μg BID

Primary Outcome Measure

Time to first severe cardiac or COPD event [ Time Frame: Up to 3 years ]

Central Contacts

Locations (234)

FacilityCityStateZIPSite coordinators
Research SiteAthensAlabama35611-
Research SiteCullmanAlabama35058-
Research SiteFairhopeAlabama36532-
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteSheffieldAlabama35660-
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